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FDA 510(k), K191274, BonAlive Granules
FDA 510(k), K191274, BonAlive Granules
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$149.00 USD
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510(K) Number: K191274
Device Name: BonAlive Granules
Manufacturer: Jimmy Lucchesi
Device Classification Name: Filler, Bone Void, Calcium Compound
Regulation Number: MQV
Classification Product Code: 05/13/2019
Date Received: 08/07/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: BonAlive Granules
Manufacturer: Jimmy Lucchesi
Device Classification Name: Filler, Bone Void, Calcium Compound
Regulation Number: MQV
Classification Product Code: 05/13/2019
Date Received: 08/07/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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